Perrigo Company has filed with the FDA an
Abbreviated New Drug Application (ANDA) for omeprazole 20mg/sodium bicarbonate
1100mg, the generic equivalent of Zegerid OTCT, and that it provided prior
notice of this filing to Schering-Plough HealthCare Products, Inc. a subsidiary
of Merck & Co., Inc., the owner of the brand regulatory approval and the Curators
of the University
of Missouri, the listed
patent owner.
On September 20, 2010, Schering-Plough filed suit alleging
patent infringement in the United States District Court of New Jersey to prevent
Perrigo from proceeding with the commercialization of this product. This action
formally initiates the process under the Hatch-Waxman Act. In addition,
Santarus, Inc. and the Curators of the University of Missouri,
licensor and owner of the patents, were joined in the lawsuits as
co-plaintiffs. In connection with litigation relating to Zegerid@ brand
prescription products, the U.S. District Court for the District of Delaware
ruled in April 2010 that the same patents that are the subject of the present
action were invalid due to obviousness. An appeal of that decision was filed in
May 2010, and the appeal is pending.
The Perrigo product is generic equivalent to
Schering-Plough’s Zegerid-OTCT (omeprazole 20 mg/sodium bicarbonate 1100mg) a
proton pump inhibitor and antacid indicated for the treatment of frequent heartburn.
Sales for the OTC brand are estimated to be approximately $60 million
annualized from the most recent month, according to IRI.
Perrigo’s Chairman and CEO Joseph C. Papa stated, “This
filing is an example of our focus on bringing new Rx to OTC switch products to market.
It is a great addition to our diverse offering of gastrointestinal products.”
